Good morning, and welcome to the InspireMD Second Quarter 2023 Earnings Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to Glenn Garmont with LifeSci Advisors. Thank you. You may begin.

Thank you, operator. Good morning, everyone. Thank you for joining us for the InspireMD Second Quarter 2023 Financial Results and Corporate Update Conference Call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer. During this call, management will be making forward-looking statements, not historical facts and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. They involve risks and uncertainties that may cause actual results to differ materially from those expressed in the forward-looking statements. For more information about these risks, please refer to the risk factors described in InspireMD's most recently filed periodic reports on Form 10-K and Form 10-Q, filed with the U.S. Securities and Exchange Commission, and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. The call contains time-sensitive information that is accurate only as of today, August 8, 2023. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It's now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Thank you, Glenn, and thanks to everyone for joining our call this morning. I'm pleased to share that the second quarter of 2023 proved to be a transformational time for our company, as we advanced our mission to lead the carotid revascularization market with next-generation solutions built on the foundation of our CGuard carotid stent platform. The second quarter produced our highest revenue to date for our CGuard Carotid Stent System, as well as the successful financing of up to $113.6 million in new capital. Specific to our financials, we generated total revenue of $1.649 million, our highest CGuard quarterly revenue to date, representing growth of nearly 10% over the second quarter of 2022 and sequential growth of 33% over the first quarter of 2023. We sold 2,804 stent systems during the quarter as compared to 2,602 during the second quarter of 2022, and 2033 during the first quarter of 2023. Procedural volume continues to be the key metrics of our success, measuring unit volume and market utilization. This record quarterly performance reflects the acceleration in use of CGuard EPS in our approved CE Mark territories, as we continue to focus on growing share. Foundationally, we have established a baseline of real-world experience and best-in-class data, with more than 40,000 CGuard stents sold to date. As we drive market awareness and global expansion, implant performance will remain the cornerstone of our focus. We announced in May the completion of a private placement financing of up to $113.6 million, with $42.2 million upon closing of the transaction, followed by issuance of warrants for an additional $71.4 million tied to the achievement of 4 prespecified milestones, or $17.5 (sic) [ $17.85 ] million each. The tranches are tied to the following milestones, with warrants expiring 20 trading days following. The first tranche…

[Operator Instructions] Our first question comes from the line of Adam Maeder with Piper Sandler.

Marvin, congrats on the progress. And Craig, wishing you a speedy recovery. Maybe to start, Marvin, I just wanted to go a little bit deeper on the performance outside the U.S., just kind of better understand what drove the nice quarter share capture versus better market dynamics. It sounds like there's maybe a little bit of catch-up as well. So I just wanted to go a little bit deeper on the Q2 results. And then I'll lump the second part of the question. Just on Q3 and Q4, I know you don't have guidance out there in the public domain, but just any broad strokes or color that you can provide on the back half of the year.

Adam, thanks for the question. As it relates to our strategy in Europe, there was a bit of catch-up as you referenced there, just in terms of us being able to transition that backlog. But I think in general, the market strength continues to grow, and carotid stenting continues to be our focus day to day. We're in the field working with our customers and our distributor partners. And I think this is a payoff for a lot of investment in that marketplace. Now that we have worked our way through the MDD, MDR scenario, we're kind of back to normal operating cadence, and continue to drive utilization and work in the field. This is a touch business, as you know, and I think we've assembled a very good group of distributors and a great team, and we're just continuing to execute on a day-to-day basis. So the market continues to strengthen, and I think we continue to create awareness. For example, at the LINC conference in Leipzig this year, we had 2 live cases. It was a well-attended conference. And so I think, generally speaking, that exposure helps us as does our work in the IDE trial in the U.S. So we really do operate in a global environment as it relates to vascular specialists. And so we're really pleased with those results, and we'll continue to invest in that area. As it relates to your question for Q3 and Q4, there is definitely a seasonal impact for Q3 that we all tend to predict in the European market. But on balance, I think our expectation is that we will continue to advance the numbers and grow share and build our business and strengthen things as it relates to our European -- and by the way, served market. So it's 30 markets, not just in Europe, but South America as well.

Okay. Great. That's helpful color, Marvin. I appreciate that. And the next question that I have is just around the NCD here in the United States, just kind of a bigger-picture, open-ended question for you. What are your key takeaways from the proposed memo? How do you think about implications for your business and the broader market if finalized?

Yes. So it's a great question and certainly a contemporary topic that we're all discussing. First, we believe that the proposed coverage decision, first and foremost, is good for patients. So I think above everything else, opening procedural options that otherwise haven't been available to patients, that will yield better outcomes and better discussion and decisions with their physicians, is good. And I think clearly we benefit from this broadening of coverage, as we're building a business around a technology platform that's intended to be this catalyst for changing standard of care, with the broadest set of delivery options, and we believe the best implant alternative in the marketplace. So we see this as a great direction, and as the proposed coverage decision continues to unfold, we support the decision memo and certainly look forward to that final decision in October. But on balance, I think this really just helps this market transition as a whole. And we're poised to take full advantage of this as we've invested in this carotid space for many years. And we think the timing is perfectly suited for CGuard and what we've been able to demonstrate in terms of patient outcomes. So we're really energized by the direction here and building our business around it.

Very helpful, Marvin. And couple more, if I may. I next wanted to ask about the TCAR system, SwitchGuard. Just wanted to kind of better understand commercial time lines there, both in the U.S. and Europe, as well as what the regulatory strategy pathway looks like. I think it's crystal clear in terms of time lines for CGuard what you've talked about today. But I wanted to just get a little bit more color on the TCAR system in particular.

Yes. So we continue to advance our work in that area. Right now, Adam, I would characterize it this way: we're following a regulatory pathway at this point, which will certainly be determined by studying the system following a protocoled approach, and we're sort of looking for guidance from that regulatory effort. And so I think we've been able to develop a very interesting system, and are looking forward to studying that in real market access, both in Europe and in the U.S. And so I think we'll be able to provide a bit more detail as it relates to specific time lines. But as we work through the regulatory pathway, there's still some clarity in that, that we're looking for just in terms of overall -- just of overall feedback. We're meeting with the FDA this quarter to sort of finalize some of the last touches on protocol and direction. So we hope that, that's positive, and we can begin to study this in a practical form.

Helpful, Marvin. And not to press too much here, but you talked about CGuard potential commercial launch in the United States in the first half of 2025. Is it reasonable to assume that the TCAR system, SwitchGuard could come in the not-too-distant future after that, subsequent quarters or -- just want to make sure, just broadly speaking, I have time lines right for the TCAR product.

Yes. So great. So it's a very good question, Adam. And again, we're waiting for sort of final feedback from FDA on this topic. But our expectation is that the approval of our CGuard stent system will run concurrent with our studying of TCAR and the short shaft system, as the stent itself and the device itself is the same. And then we'll be able to -- to be able to take advantage of that approval process on the stent system, and concurrent approval or close to a concurrent approval with SwitchGuard, all things being equal. Obviously, we have to study the TCAR device itself, but the stent system remains the same. And so we're hopeful that we'll be able to parlay that into a fairly quick approval process for both, on or about the same timeline.

Okay. Perfect. And then just the one last question for me. Just on the go-to-market strategy in the U.S., maybe you can speak a little bit to kind of how you're getting prepared. You talked about pre-commercial activities in the prepared remarks. Just elaborate on that, please? And how are you thinking about kind of building out a sales team and the infrastructure ahead of that first half '25 time line?

So sure, no problem. So about 5 months ago, we hired Shane Gleason to run the U.S. business and as the VP of Global Marketing. And that was the first step in a sequence of architecting our plan for a direct sales organization and support structure in the U.S. And so Shane has taken on the challenge of building that enterprise and beginning to put in place all the pieces, both operationally as well as how we'll plan our go-to-market strategy. But I think it's safe to assume that we're going to build a world-class sales organization and support structure. And the ability to serve multiple subspecialties within this community, both vascular surgeons as well as interventionals. And so I think we're building that plan out, and we'll continue to invest in that over the next 18 months until we get to a point where we're able to launch. But the whole point here is to create a lead-in for our approval process in the U.S., and so we can have a very warm start and take full advantage of this tailwind that's been created, both with the NCD and just overall stenting as a whole. So we're looking forward to leveraging our European experience and parlaying that into a strong U.S. launch.

Our next question comes from the line of Benjamin Haynor with Alliance Global Partners.

Marvin. Now that you've got C-Guardians enrollment wrapped up, it seems like everything is moving along well. What's going to take most of your focus? I mean you've got the FDA meeting coming up this quarter, but beyond that -- and the precommercial activities. What are you and the management team going to be most focused on in the coming quarters until the C-Guardian is [ released ] out?

Ben, thanks for the question. So there's a tremendous amount of work, as you know, related to executing on the PMA in order for us to accomplish that approval goal in 2025. So the team is working hard to make sure that now that enrollment is complete, we're following all the necessary steps to get to the PMA approval. Certainly studying SwitchGuard in the context of its own regulatory pathway is a tremendous amount of work as well. And then finally, just managing and maintaining our growth plan and strategy in Europe. So I would characterize it this way. We're in, very much in execution mode. Now that our financing has been accomplished and we've been able to secure good funds going forward, it's all about putting our heads down and executing on these milestones that we've set forth. I think it's a pretty clear pathway at this point, but nothing is easy, and we're all focused on making sure that we manage all these variables successfully so that we can meet these commitments.

Okay. Great, no, that's helpful. And then you mentioned internationally. Any plan to kind of go direct, any changes to the commercial organization that take place outside the U.S. here?

Yes, Ben, I think we've discussed this at length. We continue to evaluate every one of our international markets and try to figure out what the best go-to-market strategy is for that. We want to certainly keep the momentum and the growth going. But in terms of any immediate shifts toward making changes in our current go-to-market strategy outside the U.S., we're pretty much stable for the moment. I think it's in our best interest to focus our attention in the U.S. and many of the tasks that are in front of us related to building a direct organization, which is not a small task to accomplish. So we don't want to distract ourselves from the next 18 months' effort to get a successful U.S. launch. And I think we've been able, under great leadership in Europe, to stabilize our distributor partners and kind of maintain that cadence for growth.

Okay. That certainly makes sense. And then just maybe I didn't catch this correctly. But on the CE Mark recertification, it sounds like you're in document review by the notified body, and that will kind of get everything complete for the MDR. Is that where you're at? And is that correct?

Yes, that's correct, Ben. We were actually given the all clear by our notified body, and it's in the midst of document review within the European health system for those final touches of review, which seem to take a life of their own, as we've all come to expect with this MDR process. But I think we're in good shape and expect that to be officially formalized in the coming weeks. But as it relates to our ability to continue to ship and sell in Europe, we're in good shape there under the MDR -- the MDD certification that we reestablished in April.

Okay. Got it. And then lastly for me, more of a housekeeping question. On G&A, [ and ]less again, I don't know, $400,000 or so of legal expenses and miscellaneous expenses. Are those things that you expect not to recur, maybe associated with the transaction that you had during the quarter? Or what's the right way to think about those?

So actually, Amir Kohen is with us today, who is our Senior VP of Finance. And maybe I'll let Amir address that question, in the absence of Craig being with us, if that's okay.

So there is some increase in legal expenses. Half of it relates to actually expense in prepaid expenses from last year, so it's noncash and it's nonrecurring. And I think it's from a specific transaction we had to do after the fundraising, including share-based compensation and grant letters, and et cetera.

So the simple answer, Ben, is that it's nonreoccurring (sic) [ nonrecurring ]. And those were calculated both through last year as well as through our fund raise. So we're set for that.

Congrats on the progress.

This concludes our question-and-answer session. I would like to turn the conference back over to Marvin Slosman for any closing remarks. Marvin?

Yes. Thanks again for everyone for joining the call today, and we're very encouraged by our progress into 2023, and look forward to the balance of the year being very successful time for InspireMD. Thanks for joining.